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市場調查報告書
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1790278

美國滅菌監測市場規模、佔有率和趨勢分析報告：按技術、產品、方法、最終用途和細分市場預測，2025 年至 2033 年

U.S. Sterilization Monitoring Market Size, Share & Trends Analysis Report By Technology (Biological Indicators, Chemical Indicators), By Product (Strips, Indicator Tapes), By Method (Steam Sterilization), By End-use, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 300 Pages | 商品交期: 2-10個工作天內

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美國滅菌監測市場概況

美國滅菌監測市場規模預計在 2024 年為 2.318 億美元，預計到 2033 年將達到 3.823 億美元，2025 年至 2033 年的複合年成長率為 5.76%。這一成長是由醫療相關感染 (HAI) 的增加、感染控制意識和監管要求所推動的。

美國衛生與公眾服務部疾病預防與健康促進辦公室、衛生服務部助理部長估計，在任何時候，全國每 31 名住院患者中就有 1 名患有至少一種醫院相關感染 (HAI)，導致美國每年發生超過 680,000 起感染疾病，並產生數十億美元的與 HAI 相關的額外醫療費用。

美國的滅菌監測產業主要受到對感染控制、病人安全和法規遵循日益成長的關注的推動。隨著醫療機構努力預防醫院相關感染 (HAI)，對有效滅菌過程和監測解決方案的需求顯著增加。根據美國疾病管制與預防中心的說法，滅菌監測是確保儀器和設備得到適當滅菌並確保病人後續使用安全的重要過程。此外，醫療設備使用各種方法滅菌，包括濕熱（蒸氣）、乾熱、輻射、環氧乙烷 (EtO) 氣體、汽化過氧化氫、二氧化氯氣體、汽化過乙酸和二氧化氮。因此，醫療設備產業的成長進一步推動了美國市場的發展。

該市場包括用於檢驗滅菌程序有效性的各種產品和技術，包括生物指示劑、化學指示劑、滅菌積分器和自動監控系統。

市場成長的關鍵驅動力之一是醫院、外科中心、牙科診所和生物製藥生產設施對滅菌監測產品的日益普及。尤其是醫院，它們面臨巨大的監管壓力，必須遵守美國美國食品藥物管理局管理局 (FDA)、美國疾病管制與預防中心 (CDC) 和美國醫療設備促進協會 (AAMI) 等組織制定的標準。這些組織規定了嚴格的滅菌通訊協定，要求準確可靠的監測，以確保設備無菌和病人安全。因此，醫療保健提供者正在增加對先進滅菌監測技術的投資，這些技術可以提供即時數據、自動記錄和合規性報告功能。

目錄

第1章調查方法與範圍

第2章執行摘要

第3章美國滅菌監測市場變數、趨勢與範圍

  • 市場體系展望
    • 補貼市場前景
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
    • 市場機會分析
    • 市場問題分析
  • 美國滅菌監測市場分析工具
    • 產業分析—波特五力分析
    • PESTEL分析

第4章美國滅菌監測市場：依技術、估計和趨勢分析

  • 細分儀表板
  • 美國滅菌監測市場技術變革分析
  • 2021 年至 2033 年美國滅菌監測市場規模及趨勢分析（依技術）
  • 生物指標
  • 化學指標

第5章美國滅菌監測市場：產品、估計與趨勢分析

  • 細分儀表板
  • 美國滅菌監測市場的產品差異分析
  • 2021 年至 2033 年美國滅菌監測市場規模及趨勢分析（依產品）
  • 條
  • 指示帶
  • 卡片
  • 其他

第6章美國滅菌監測市場：依方法、估計和趨勢分析

  • 細分儀表板
  • 美國滅菌監測市場方法論變化分析
  • 美國滅菌監測市場規模及趨勢分析（依方法，2021-2033）
  • 蒸氣滅菌
  • 環氧乙烷滅菌
  • 過氧化氫滅菌
  • 其他

第7章美國滅菌監測市場：依最終用途的估計和趨勢分析

  • 細分儀表板
  • 美國滅菌監測市場最終用途變化分析
  • 美國滅菌監測市場規模及趨勢分析（依最終用途），2021-2033
  • 醫院和診所
  • 生物製藥/生技公司
  • 門診手術中心
  • 研究和學術機構
  • 其他

第8章 競爭態勢

  • 市場參與企業分類
  • 主要企業簡介
    • 3M
    • ASP
    • STERIS
    • Solventum
    • Getinge
    • Propper Manufacturing Co., Inc.
    • Mesa Labs, Inc.
    • Hu-Friedy Mfg. Co., LLC.
    • Terragene
    • Tuttnauer
    • True Indicating
  • 2024年公司市場佔有率分析
  • 其他主要市場參與企業名單
Product Code: GVR-4-68040-685-8

U.S. Sterilization Monitoring Market Summary

The U.S. sterilization monitoring market size was estimated at USD 231.8 million in 2024 and is projected to reach USD 382.3 million by 2033, growing at a CAGR of 5.76% from 2025 to 2033. This growth is driven by the rising healthcare associated infections (HAIs), awareness of infection control, and regulatory mandates.

According to estimates from the Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, U.S. Department of Health and Human Services, in hospitals nationwide, at any given time, 1 in 31 hospitalized patients has at least one healthcare-associated infection (HAI). Annually, there are over 680,000 infections and billions of dollars in additional healthcare costs linked to HAIs across the U.S.

The sterilization monitoring industry in the U.S. is primarily driven by the increasing emphasis on infection control, patient safety, and regulatory compliance. As healthcare facilities strive to prevent healthcare-associated infections (HAIs), the demand for effective sterilization processes and monitoring solutions has grown significantly. According to U.S. Centers for Disease and Prevention, sterilization monitoring is an essential process to confirm that instruments and devices are properly sterilized and safe for use on subsequent patients. Furthermore, medical devices are sterilized through various methods, such as moist heat (steam), dry heat, radiation, ethylene oxide (EtO) gas, vaporized hydrogen peroxide, and other techniques such as chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide. Hence, the growing industry of medical devices is further boosting the market in the U.S.

This market encompasses a range of products and technologies designed to verify the efficacy of sterilization procedures, including biological indicators, chemical indicators, sterilization integrators, and automated monitoring systems.

One of the primary drivers of market growth is the rising adoption of sterilization monitoring products across hospitals, surgical centers, dental clinics, and biopharmaceutical manufacturing units. Hospitals, in particular, are under stringent regulatory pressures to adhere to standards set by agencies such as the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the Association for the Advancement of Medical Instrumentation (AAMI). These organizations mandate rigorous sterilization protocols, which necessitate accurate and reliable monitoring to ensure device sterility and patient safety. As a result, healthcare providers are increasingly investing in advanced sterilization monitoring technologies that offer real-time data, automated recording, and compliance reporting capabilities.

U.S. Sterilization Monitoring Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. sterilization monitoring market report based on technology, product, method, and end-use:

  • Technology Outlook (Revenue, USD Million, 2021 - 2033)
  • Biological Indicators
  • Chemical indicators
  • Product Outlook (Revenue, USD Million, 2021 - 2033)
  • Strips
  • Indicator Tapes
  • Cards
  • Others
  • Method Outlook (Revenue, USD Million, 2021 - 2033)
  • Steam Sterilization
  • Ethylene Oxide Sterilization
  • Hydrogen Peroxide Sterilization
  • Others
  • End-use Outlook (Revenue, USD Million, 2021 - 2033)
  • Hospitals and Clinics
  • Biopharma/Biotech Companies
  • Ambulatory Surgery Centers
  • Research and Academic Institutes
  • Other End-Use

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Technology
    • 1.2.2. Product
    • 1.2.3. Method
    • 1.2.4. End Use
  • 1.3. Estimates and Forecast Timeline
  • 1.4. Research Methodology
  • 1.5. Information Procurement
    • 1.5.1. Purchased Database
    • 1.5.2. GVR's Internal Database
    • 1.5.3. Secondary Sources
    • 1.5.4. Primary Research
    • 1.5.5. Information Analysis
    • 1.5.6. Data Analysis Models
  • 1.6. Market Formulation & Data Visualization
  • 1.7. Model Details
    • 1.7.1. Commodity Flow Analysis
  • 1.8. List of Secondary Sources
  • 1.9. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
  • 2.3. Competitive Insights

Chapter 3. U.S. Sterilization Monitoring Market Variables, Trends, & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Ancillary Market Outlook
  • 3.2. Market Dynamics
    • 3.2.1. Market Driver Analysis
      • 3.2.1.1. Increasing Healthcare-Associated Infections (HAIs)
      • 3.2.1.2. Growing focus on patient safety and infection control in hospitals
      • 3.2.1.3. Rising number of inpatient surgeries
    • 3.2.2. Market Restraint Analysis
      • 3.2.2.1. High costs of sterilization monitoring systems
      • 3.2.2.2. Technological limitations
    • 3.2.3. Market Opportunities Analysis
      • 3.2.3.1. Growing adoption of automated monitoring systems
      • 3.2.3.2. Technological innovations
    • 3.2.4. Market Challenges Analysis
      • 3.2.4.1. Stringent regulatory compliance
      • 3.2.4.2. Intense market competition
  • 3.3. U.S. Sterilization Monitoring Market Analysis Tools
    • 3.3.1. Industry Analysis - Porter's
      • 3.3.1.1. Bargaining power of suppliers
      • 3.3.1.2. Bargaining power of buyers
      • 3.3.1.3. Threat of substitutes
      • 3.3.1.4. Threat of new entrants
      • 3.3.1.5. Competitive rivalry
    • 3.3.2. PESTEL Analysis
      • 3.3.2.1. Political & Legal Landscape
      • 3.3.2.2. Economic and Social Landscape
      • 3.3.2.3. Technological landscape

Chapter 4. U.S. Sterilization Monitoring Market: Technology Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. U.S. Sterilization Monitoring Market Technology Movement Analysis
  • 4.3. U.S. Sterilization Monitoring Market Size & Trend Analysis, by Technology, 2021 to 2033 (USD Million)
  • 4.4. Biological Indicators
    • 4.4.1. Biological Indicators U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5. Chemical indicators
    • 4.5.1. Chemical indicators U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Sterilization Monitoring Market: Product Estimates & Trend Analysis

  • 5.1. Segment Dashboard
  • 5.2. U.S. Sterilization Monitoring Market Product Movement Analysis
  • 5.3. U.S. Sterilization Monitoring Market Size & Trend Analysis, by Product, 2021 to 2033 (USD Million)
  • 5.4. Strips
    • 5.4.1. Strips U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5. Indicator Tapes
    • 5.5.1. Indicator Tapes U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.6. Cards
    • 5.6.1. Cards U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.7. Others
    • 5.7.1. Others U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Sterilization Monitoring Market: Method Estimates & Trend Analysis

  • 6.1. Segment Dashboard
  • 6.2. U.S. Sterilization Monitoring Market Method Movement Analysis
  • 6.3. U.S. Sterilization Monitoring Market Size & Trend Analysis, by Method, 2021 to 2033 (USD Million)
  • 6.4. Steam Sterilization
    • 6.4.1. Steam Sterilization U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5. Ethylene Oxide Sterilization
    • 6.5.1. Ethylene Oxide Sterilization U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6. Hydrogen Peroxide Sterilization
    • 6.6.1. Hydrogen Peroxide Sterilization U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.7. Others
    • 6.7.1. Others Sterilization U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Sterilization Monitoring Market: End Use Estimates & Trend Analysis

  • 7.1. Segment Dashboard
  • 7.2. U.S. Sterilization Monitoring Market End-Use Movement Analysis
  • 7.3. U.S. Sterilization Monitoring Market Size & Trend Analysis, by End-Use, 2021 to 2033 (USD Million)
  • 7.4. Hospitals and Clinics
    • 7.4.1. Hospitals and Clinics U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5. Biopharma/Biotech Companies
    • 7.5.1. Biopharma/Biotech Companies U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6. Ambulatory Surgery Centers
    • 7.6.1. Ambulatory Surgery Centers U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7. Research and Academic Institutes
    • 7.7.1. Research and Academic Institutes U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8. Other End Use
    • 7.8.1. Other End Use U.S. Sterilization Monitoring Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

  • 8.1. Market Participant Categorization
  • 8.2. Key Company Profiles
    • 8.2.1. 3M
      • 8.2.1.1. Company Overview
      • 8.2.1.2. Financial Performance
      • 8.2.1.3. Product Benchmarking
      • 8.2.1.4. Strategic Initiatives
    • 8.2.2. ASP
      • 8.2.2.1. Company Overview
      • 8.2.2.2. Financial Performance
      • 8.2.2.3. Product Benchmarking
      • 8.2.2.4. Strategic Initiatives
    • 8.2.3. STERIS
      • 8.2.3.1. Company Overview
      • 8.2.3.2. Financial Performance
      • 8.2.3.3. Product Benchmarking
      • 8.2.3.4. Strategic Initiatives
    • 8.2.4. Solventum
      • 8.2.4.1. Company Overview
      • 8.2.4.2. Financial Performance
      • 8.2.4.3. Product Benchmarking
      • 8.2.4.4. Strategic Initiatives
    • 8.2.5. Getinge
      • 8.2.5.1. Company Overview
      • 8.2.5.2. Financial Performance
      • 8.2.5.3. Product Benchmarking
      • 8.2.5.4. Strategic Initiatives
    • 8.2.6. Propper Manufacturing Co., Inc.
      • 8.2.6.1. Company Overview
      • 8.2.6.2. Financial Performance
      • 8.2.6.3. Product Benchmarking
      • 8.2.6.4. Strategic Initiatives
    • 8.2.7. Mesa Labs, Inc.
      • 8.2.7.1. Company Overview
      • 8.2.7.2. Financial Performance
      • 8.2.7.3. Product Benchmarking
      • 8.2.7.4. Strategic Initiatives
    • 8.2.8. Hu-Friedy Mfg. Co., LLC.
      • 8.2.8.1. Company Overview
      • 8.2.8.2. Financial Performance
      • 8.2.8.3. Product Benchmarking
      • 8.2.8.4. Strategic Initiatives
    • 8.2.9. Terragene
      • 8.2.9.1. Company Overview
      • 8.2.9.2. Financial Performance
      • 8.2.9.3. Product Benchmarking
      • 8.2.9.4. Strategic Initiatives
    • 8.2.10. Tuttnauer
      • 8.2.10.1. Company Overview
      • 8.2.10.2. Financial Performance
      • 8.2.10.3. Product Benchmarking
      • 8.2.10.4. Strategic Initiatives
    • 8.2.11. True Indicating
      • 8.2.11.1. Company Overview
      • 8.2.11.2. Financial Performance
      • 8.2.11.3. Product Benchmarking
      • 8.2.11.4. Strategic Initiatives
  • 8.3. Company Market Share Analysis, 2024
  • 8.4. List of Other Key Market Players

List of Tables

  • Table 1 List of Secondary Sources
  • Table 2 List of Abbreviations
  • Table 3 U.S. Sterilization Monitoring Market, by Technology, 2021 - 2033 (USD Million)
  • Table 4 U.S. Sterilization Monitoring Market, by Product, 2021 - 2033 (USD Million)
  • Table 5 U.S. Sterilization Monitoring Market, by Method, 2021 - 2033 (USD Million)
  • Table 6 U.S. Sterilization Monitoring Market, by End-Use, 2021 - 2033 (USD Million)
  • Table 7 Participant's Overview
  • Table 8 Financial Performance
  • Table 9 Product Benchmarking
  • Table 10 Strategic Initiatives

List of Figures

  • Fig. 1 Information Procurement
  • Fig. 2 Primary Research Pattern
  • Fig. 3 Market Research Approaches
  • Fig. 4 Value Chain-Based Sizing & Forecasting
  • Fig. 5 Market Formulation & Validation
  • Fig. 6 U.S. Sterilization Monitoring Market, Market Segmentation
  • Fig. 7 Market Driver Analysis (Current & Future Impact)
  • Fig. 8 Market Restraint Analysis (Current & Future Impact)
  • Fig. 9 Market Opportunity Analysis (Current & Future Impact)
  • Fig. 10 SWOT Analysis, By Factor (Political & Legal, Economic and Technological)
  • Fig. 11 Porter's Five Forces Analysis
  • Fig. 12 Regional Marketplace: Key Takeaways
  • Fig. 13 U.S. Sterilization Monitoring Market, for Technology, 2021 - 2033 (USD Million)
  • Fig. 14 U.S. Sterilization Monitoring Market, for Biological Indicators, 2021 - 2033 (USD Million)
  • Fig. 15 U.S. Sterilization Monitoring Market, for Chemical indicators, 2021 - 2033 (USD Million)
  • Fig. 16 U.S. Sterilization Monitoring Market, for Strips, 2021 - 2033 (USD Million)
  • Fig. 17 U.S. Sterilization Monitoring Market, for Indicator Tapes, 2021 - 2033 (USD Million)
  • Fig. 18 U.S. Sterilization Monitoring Market, for Cards, 2021 - 2033 (USD Million)
  • Fig. 19 U.S. Sterilization Monitoring Market, for Others, 2021 - 2033 (USD Million)
  • Fig. 20 U.S. Sterilization Monitoring Market, for Method, 2021 - 2033 (USD Million)
  • Fig. 21 U.S. Sterilization Monitoring Market, for Steam Sterilization, 2021 - 2033 (USD Million)
  • Fig. 22 U.S. Sterilization Monitoring Market, for Ethylene Oxide Sterilization, 2021 - 2033 (USD Million)
  • Fig. 23 U.S. Sterilization Monitoring Market, for Hydrogen Peroxide Sterilization, 2021 - 2033 (USD Million)
  • Fig. 24 U.S. Sterilization Monitoring Market, for Others, 2021 - 2033 (USD Million)
  • Fig. 25 U.S. Sterilization Monitoring Market, for End Use, 2021 - 2033 (USD Million)
  • Fig. 26 U.S. Sterilization Monitoring Market, for Hospitals and Clinics, 2021 - 2033 (USD Million)
  • Fig. 27 U.S. Sterilization Monitoring Market, for Biopharma/Biotech Companies, 2021 - 2033 (USD Million)
  • Fig. 28 U.S. Sterilization Monitoring Market, for Ambulatory Surgery Centers, 2021 - 2033 (USD Million)
  • Fig. 29 U.S. Sterilization Monitoring Market, for Research and Academic Institutes, 2021 - 2033 (USD Million)
  • Fig. 30 U.S. Sterilization Monitoring Market, for Other End-Use, 2021 - 2033 (USD Million)